# Auvelity於2022年首次核准用於治療成人重度憂鬱症，是首款獲准用於阿茲海默症相關失智躁動症狀的非抗精神病藥物。

*biotech · news · 2026-05-08 · Medical Xpress*

## Key points

- FDA核准Auvelity用於成人阿茲海默症相關失智的躁動症狀。
- Auvelity是首款獲准用於阿茲海默症失智相關躁動的非抗精神病藥物。
- 核准基於一項為期五週的試驗，顯示在躁動評分上較安慰劑有顯著改善。
- 持續使用Auvelity的患者躁動復發時間較換用安慰劑者更長。
- 兩項隨機臨床試驗證實療效，支持擴大核准範圍。

The U.S. Food and Drug Administration has approved the expanded use of Axsome Therapeutics' Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat adults with agitation associated with dementia due to Alzheimer's disease. Auvelity was initially approved in 2022 to treat major depressive disorder in adults and is the first nonantipsychotic approved for agitation associated with dementia due to Alzheimer's disease. The approval was based on a five-week trial in which participants received either Auvelity or a placebo. Those randomly assigned to Auvelity showed a significantly greater change in the primary end point of total score of the Cohen-Mansfield Agitation Inventory based on caregiver reports. Among those who achieved a response, those who were randomly assigned to continue Auvelity treatment had a significantly longer time to relapse of agitation symptoms versus patients subsequently assigned to receive placebo. "Auvelity was found to be efficacious for treating agitation in Alzheimer's disease in two randomized trials and now represents an additional option to address one of the most difficult sequelae of the disease, especially as it progresses," Tracy Beth Hoeg, M.D., Ph.D., from the FDA Center for Drug Evaluation and Research, said in a statement. "We hope this approval will provide meaningful benefit to patients, their families, and caregivers."

**Companies:** Axsome Therapeutics
**Countries:** United States

[Read the full story on Medical Xpress](https://medicalxpress.com/news/2026-05-fda-auvelity-alzheimer-disease-agitation.html)

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